A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
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| ClinicalTrials.gov Identifier: NCT04722146 |
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Recruitment Status :
Recruiting
First Posted : January 25, 2021
Last Update Posted : July 15, 2022
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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Brief Summary:
The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: Teclistamab Drug: Daratumumab Drug: Pomalidomide Drug: Lenalidomide Drug: Bortezomib Drug: Nirogacestat | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 146 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma |
| Actual Study Start Date : | March 12, 2021 |
| Estimated Primary Completion Date : | May 19, 2023 |
| Estimated Study Completion Date : | September 6, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide
Participants will receive teclistamab plus daratumumab plus pomalidomide.
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Drug: Teclistamab
Participants will receive teclistamab.
Other Name: JNJ-64007957 Drug: Daratumumab Participants will receive daratumumab. Drug: Pomalidomide Participants will receive pomalidomide. |
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Experimental: Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles)
Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles.
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Drug: Teclistamab
Participants will receive teclistamab.
Other Name: JNJ-64007957 Drug: Daratumumab Participants will receive daratumumab. Drug: Lenalidomide Participants will receive lenalidomide. Drug: Bortezomib Participants will receive bortezomib. |
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Experimental: Treatment Regimen C: Teclistamab + Nirogacestat
Participants will receive teclistamab plus nirogacestat.
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Drug: Teclistamab
Participants will receive teclistamab.
Other Name: JNJ-64007957 Drug: Nirogacestat Participants will receive nirogacestat. |
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Experimental: Treatment Regimen D: Teclistamab + Lenalidomide
Participants will receive teclistamab plus lenalidomide.
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Drug: Teclistamab
Participants will receive teclistamab.
Other Name: JNJ-64007957 Drug: Lenalidomide Participants will receive lenalidomide. |
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Experimental: Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide
Participants will receive teclistamab plus daratumumab plus lenalidomide.
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Drug: Teclistamab
Participants will receive teclistamab.
Other Name: JNJ-64007957 Drug: Daratumumab Participants will receive daratumumab. Drug: Lenalidomide Participants will receive lenalidomide. |
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Experimental: Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)
Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles.
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Drug: Teclistamab
Participants will receive teclistamab.
Other Name: JNJ-64007957 Drug: Daratumumab Participants will receive daratumumab. Drug: Lenalidomide Participants will receive lenalidomide. Drug: Bortezomib Participants will receive bortezomib. |
Primary Outcome Measures :
- Number of Participants with Incidence of Adverse Events (AEs) [ Time Frame: Up to 2 year and 5 months ]An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
- Number of Participants with AEs by Severity [ Time Frame: Up to 2 year and 5 months ]Number of participants with AEs by severity will be reported.
- Number of Participants with Abnormalities in Laboratory Values [ Time Frame: Up to 2 year and 5 months ]Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.
- Number of Participants with Dose-Limiting Toxicity (DLT) [ Time Frame: Up to Cycle 2 Day 21 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B) ]The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.
Secondary Outcome Measures :
- Overall Response Rate (ORR) [ Time Frame: Up to 2 year and 5 months ]ORR is defined as the proportion of participants who achieve partial response (PR) or better according to the international myeloma working group (IMWG) 2016 criteria.
- Very Good Partial Response (VGPR) or Better Response Rate [ Time Frame: Up to 2 year and 5 months ]VGPR or better response rate is defined as the proportion of participants who achieve a VGPR or better response (stringent complete response [sCR]+ complete response [CR]+VGPR) according to the IMWG 2016 criteria.
- Complete Response (CR) or Better Response Rate [ Time Frame: Up to 2 year and 5 months ]CR or better response rate is defined as the proportion of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.
- Stringent Complete Response (sCR) Rate [ Time Frame: Up to 2 year and 5 months ]sCR rate is defined as the proportion of participants who achieve an sCR according to the IMWG 2016 criteria.
- Duration of Response [ Time Frame: Up to 2 year and 5 months ]Duration of response is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria.
- Time to Response [ Time Frame: Up to 2 year and 5 months ]Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better.
- Serum Concentrations of Teclistamab [ Time Frame: Up to 2 year and 5 months ]Serum concentrations of teclistamab will be reported.
- Serum Concentrations of Daratumumab [ Time Frame: Up to 2 year and 5 months ]Serum concentrations of daratumumab will be reported.
- Serum Concentrations of Nirogacestat [ Time Frame: Up to 2 year and 5 months ]Serum concentration of nirogacestat will be reported.
- Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab [ Time Frame: Up to 2 year and 5 months ]Number of participants with anti-drug antibodies to teclistamab will be reported for all treatment regimens.
- Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab [ Time Frame: Up to 2 year and 5 months ]Number of participants with anti-drug antibodies to daratumumab will be reported for Treatment Regimen A, B, E and F.
- Number of Participants with Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20) [ Time Frame: Up to 2 year and 5 months ]Number of participants with anti-drug antibodies to rHuPH20 will be reported for Treatment Regimen A, B, E and F.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
- Meet treatment regimen-specific requirements as follows: Treatment Regimen A (teclistamab [tec]-daratumumab [dara]-pomalidomide [pom]) only: Participant has relapsed or refractory multiple myeloma and has received 1 to 3 prior lines of therapy, including exposure to a proteasome inhibitor (PI) and lenalidomide; Treatment Regimen B (tec-dara-lenalidomide [len]-bortezomib [bor]) only: Participant has newly diagnosed or relapsed/refractory multiple myeloma and is naive to treatment with lenalidomide; Treatment Regimen C (tec-nirogacestat [niro]) only: Participant has relapsed or refractory multiple myeloma and has 1) received 3 or more prior lines of therapy or 2) is double refractory to a PI and an immunomodulatory drug (IMiD) and triple exposed to a PI, an IMiD, and an anti-cluster of differentiation (CD)38 monoclonal antibody (mAb); Treatment Regimen D (tec-len) only: Participant has multiple myeloma and has received greater than or equal to (>=) 2 prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb; Treatment Regimen E (tec-dara-len) only: Participant has newly diagnosed multiple myeloma or if previously treated has received 1 to 3 prior lines of therapy, including exposure to a PI and an IMiD; Treatment Regimen F (tec-dara-len-bor) only: Participant has newly diagnosed multiple myeloma
- Have measurable disease at screening as defined by at least one of the following: serum M-protein level >= 1.0 gram/deciliter (g/dL); or urine M-protein level >= 200 milligrams (mg)/24 hours; or light chain multiple myeloma: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligram/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
- A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [hCG]) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration and must agree to further serum or urine pregnancy tests during the study
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 100 days after the last dose of study treatment
Exclusion Criteria:
- Prior treatment with any therapy that targets B-cell maturation antigen (BCMA): This exclusion does not apply to Treatment Regimen C
- Live, attenuated vaccine within 30 days before the first dose of study treatment
- Received a cumulative dose of corticosteroids equivalent to >= 140 mg of prednisone within the 14-day period before the start of study treatment administration
- Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
- Known to be seropositive for human immunodeficiency virus
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04722146
Contacts
| Contact: Study Contact | 844-434-4210 | Participate-In-This-Study@its.jnj.com |
Locations
Show 29 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
| Study Director: | Janssen Research and Development, LLC Clinical Trial | Janssen Research and Development LLC |
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT04722146 |
| Other Study ID Numbers: |
CR108927 2020-004404-33 ( EudraCT Number ) 64007957MMY1004 ( Other Identifier: Janssen Research & Development, LLC ) |
| First Posted: | January 25, 2021 Key Record Dates |
| Last Update Posted: | July 15, 2022 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu |
| URL: | https://www.janssen.com/clinical-trials/transparency |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders |
Immune System Diseases Lenalidomide Pomalidomide Bortezomib Daratumumab Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |